Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report 7/27/2016
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 — Radiation Therapy Treatment Planning System — designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.
Recall Number Z-2206-2016
An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. — To the best of the firm’s knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.
RAYSEARCH LABORATORIES AB, Stockholm, Sweden on 7/1/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
California, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas and Washington